BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIRUS IN FOR TIBIA 9.3, L 300

    MDR report key: 3815080 · Received May 5, 2014

    Report

    Report Number
    9613350-2014-03495
    Event Type
    Other
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE AS THE NAIL STILL IMPLANTED IN THE PATIENT. NO X-RAYS OR OTHER SOURCE DOCUMENTS WERE PROVIDED. AN INVESTIGATION WITH THE PROVIDED INFORMATION WAS FINALIZED ON APRIL 29, 2014. BELOW ARE THE RESULTS OF THE INVESTIGATION. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER (SURGICAL TECHNIQUE LIT. NO. 06.00712.062X). THERE WAS NO TREND IDENTIFIED. THE EVENT DETAIL DESCRIBES THAT THE USER COULD NOT REMOVE THE NAIL DURING REVISION SURGERY. THE DEVICE ANALYSIS COULD NOT BE PERFORMED AS THE PRODUCT IS STILL IMPLANTED IN THE PATIENT. THE REMOVAL OF THE IMPLANT WAS NOT MENTIONED IN THE SURGICAL TECHNIQUE LIT. NO. 06.00712.062X. BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OT REPRODUCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE ON AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A SIRUS TI TIBIA NAIL ON UNKNOWN DATE. IT WAS STATED THAT THE DOCTOR WAS ABLE TO REMOVE A CORTICAL SCREW BUT UNABLE TO REMOVE THE NAIL FROM THE PATIENT. IT IS MENTIONED THAT THE DOCTOR ADMITTED THAT WAS NO PROBLEM WITH THE EQUIPMENT. THE INCIDENT DID NOT AFFECT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267909 SIRUS IN FOR TIBIA 9.3, L 300 SIRUS INTRAMEDULLARY NAIL-FEMORAL AND HSB ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other